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Home > "D" Clinical Trials Conditions > Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
For Condition: stage 4 breast cancer,stage 3A breast cancer,stage 3B breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.
Details: OBJECTIVES: - Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel. - Compare the toxicities and pharmacoeconomics of these four regimens in these patients. - Compare the quality of life of patients treated with these four regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no). Patients are randomized to one of four treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour on day 1. - Arm II: Patients receive paclitaxel IV over 3 hours on day 1. - Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. - Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 8 weeks. PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven unresectable locally advanced or metastatic breast cancer - Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines - At least one bidimensionally measurable lesion - No brain metastasis - No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease - Hormone receptor status: - Known hormone receptor status PATIENT CHARACTERISTICS: Age: - 18 to 75 Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - AST and ALT no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - Bilirubin normal Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled angina or arrhythmia - No myocardial infarction within the past 6 months - No New York Heart Association class III or IV heart disease Other: - No sensitive neuropathy worse than grade 2 - No other significant, uncontrolled medical or psychiatric condition - No serious active infection - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior specific antitumoral immunotherapy Chemotherapy: - See Disease Characteristics - No prior taxanes - At least 4 weeks since other prior specific antitumoral chemotherapy Endocrine therapy: - At least 4 weeks since prior specific antitumoral hormonal therapy Radiotherapy: - At least 4 weeks since prior specific antitumoral radiotherapy Surgery: - Not specified Other: - No other concurrent experimental medication
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephGligorov, Study Chair, Hopital Tenon
Clinique Fleming
Tours, , 37000
France
Clinique Hartmann
Neuilly-sur-Seine, , 92200
France
American Hospital of Paris
Neuilly-sur-Seine, , F-92202
France
Hopital Saint Joseph
Marseille, , 13008
France
Polyclinique De Courlancy
Reims, , F-51100
France
Hopital Drevon
Dijon, , 21000
France
Centre Hospitalier Laennec
Creil, , 60109
France
CH Meulan
Meulan, , 78250
France
Centre D'Oncologie Du Pays-Basque
Bayonne, , F-64100
France
Clinique Geoffroy St. Hillaire
Paris, , 75005
France
Hopital Louis Mourier
Colombes, ,
France
C.H.G. Beauvais
Beauvais, , 60021
France
Centre Hospitalier de Mulhouse
Mulhouse, , 68051
France
Hopital Intercommunal De Creteil
Creteil, , 94010
France
Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette, , L-4005
Luxembourg
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Hopital Saint Antoine
Paris, , 75571
France
Centre Hospitalier Victor Dupouy
Argenteuil, , 95107
France
Clinique de l'Orangerie
Strasbourg, , 67010
France
Hopital Notre-Dame de Bon Secours
Metz, , 57038
France
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil-les-Meaux, , 77100
France
Centre du Rouget
Sarcelles, , 95250
France
Clinique Pasteur
Toulouse, , 31076
France
Hotel Dieu de Paris
Paris, , 75181
France
Centre Hospitalier d'Antibes
Antibes, , 06606
France
Clinique Ste - Marie
Pontoise, , 95301
France
Intercommunal Hospital
Montfermeil, , 93370
France
Hopital Tenon
Paris, , 75970
France
Hopital Desgenettes - Service de Medecine Interne
Lyon, , 69998
France
Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
Gien, , 45500
France
Centre Jean Bernard
Le Mans, , 72000
France
Institut Sainte Catherine
Avignon, , 84082
France
Clinique Floreal
Bagnolet, , 28630
France
C.H. Senlis
Senlis, , 60309
France
Hopital Fontenoy
Chartres, , 28018
France
Additional Information:
Study ID Numbers: CDR0000068134; FRE-GERCOR-TAXMAX-SOO-1,EU-20029
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006120
Other Stage 4 Breast Cancer Studies:
1. Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
2. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
3. Letrozole With or Without CCI-779 in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
4. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
5. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Clinical Trials
Other Mulhouse Clinical Trials
Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
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